The article is devoted to the results of the theoretical and experimental investigations on the development of the optimal formulation of the pharmaceutical composition based on Kathiazin and Succinic acid in the solid gelatinous capsules. The glutaminic acid has been introduced into the pharmaceutical composition to improve the bioavailability of the succinic acid. The content of active pharmaceutical substances has been determined. The single dose of Kathiazin is 120 mg, succinic and glutaminic acids — 100 mg. The kind of auxiliary substances used in modern pharmaceutical technology of the solid dosage forms has been grounded according to the literature data. The pharmacotechnological testing of the active pharmaceutical ingredients and auxiliary substances used in our research work has been carried out. The pharmaco-technological properties of the substances investigated according to the articles of State Pharmacopoeia of Ukraine (2 edition) have been estimated. The assessment of obtained data allowed to elaborate the composition of the experimental capsules masses. The flowability, bulk density, angle of repose, compressibility index and Hausner ratio of the mixtures created have been investigated due to requirements of the State Pharmacopoeia of Ukraine. On the base of scientific researching the most perspective pharmaceutical composition with excellent values of the flowability, angle of repose, bulk density, compressibility index and Hausner ratio has been chosen. This composition contains mannitol as the basic excipients for capsules mass. The silicon dioxide colloidal (Aerosil®) is considered to be glidant substance which provides excellent flowability. As the result of the pharmaco-technological researches the qualitative and quantitative composition of the combined capsules based on Kathiazin and succinic acid has been developed. The testing of the pharmaco-technological parameters has proved the composition obtained is suitable to be encapsulated using different types of laboratory and industrial equipment. The elaborated combined dosage form based on Kathiazin and succinic acid may be proposed as a new original medicine with pleiotropic activity for treatment hepatitis of different origin in men with spermatogenesis disturbances.
K ey wor d s : Kathiazin, excipients, pharmaceutical composition, pharmaco-technological researches.
Kustova S.P., Boiko M.O., Vacula V.M., Matvieieva T.V., Kudria M.Ya., Seliukova N.Yu.PDF URL